An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma
Patients who have relapsed myeloma have failed treatment regimens and have had disease
progression following their last treatment regimen. Despite newer salvage therapies, their
treatment options are limited and may include best supportive care and investigational
therapy. Patients with plateau-phase myeloma have a stabilized serum M-protein level without
further tumor regression despite continued treatment. Recent evidence suggests that their
prognosis might improve with further reduction in serum M-protein or prolongation of time to
disease progression (TTP). These patients are candidates for investigational agents that
could further reduce tumor burden or increase TTP.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response or Partial Response Based on M-Protein Assessments Only
Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.
Up to 18 months
Australia: Therapeutic Goods Administration